Pursestring suture retractor and method of use

ABSTRACT

Systems, devices, and methods for endoscopically retracting a target tissue. The device includes a first shaft and a second shaft slidably coupled thereto. An internal member extends in a transverse direction from the first shaft and is configured for advancement through a penetration in the target tissue to atraumatically engage a distal surface of the target tissue after being advanced therethrough. A pair of external members extend from the second shaft generally parallel to the transverse direction. The external members are spaced apart and are configured to atraumatically engage a proximal surface of the target tissue when the internal member is moved longitudinally relative to the external members. The internal member applies traction to the target tissue when retracted past the pair of external members, which apply counter-traction to the target tissue on opposing lateral sides of the internal member, to re-shape the target tissue and enable subsequent suture placement.

CROSS-REFERENCE

This application is a divisional of U.S. patent application Ser. No.16/918,027, filed Jul. 1, 2020, which is a continuation of PCTApplication No. PCT/US2019/012538, filed Jan. 7, 2019, which claims thebenefit of U.S. Provisional Application No. 62/614,326, filed Jan. 5,2018, the entire contents of which are incorporated herein by reference.

TECHNICAL FIELD

This disclosure relates generally to devices, systems, and methods forpreparing a hollow organ, remote from the site of a surgical skinincision, for the entry of instruments to perform a surgical procedureinside the organ, and for closure of the hollow organ upon completion ofthe surgical procedure.

BACKGROUND

Many surgical procedures are commonly performed within a hollow organ orbiological structure, such as the stomach or the heart, of a patient. Anincision may be placed in an outer surface of the hollow organ toprovide for passage of instruments needed to perform the surgicalprocedure. Such surgical procedures, when performed in aminimally-invasive manner may be initiated through a small skinincision, which may be remote to the hollow organ. The surgicalinstrument may be inserted into the body of the patient through the skinincision and advanced into the hollow organ via the incision therein.Once at the hollow organ, a seal must not only be created between theincision in the hollow organ and the operative instrument during thesurgical procedure, but the incision must also be closed upon completionof the procedure, to prevent loss of internal contents of the organ intothe surrounding tissue. For example, it is deleterious to allow leakageof caustic acidic stomach contents into the abdominal cavity whileperforming a surgical procedure on the stomach. If the surgicalprocedure involves entry into the heart, control and subsequent closureof the heart access incision can be particularly important, as positiveblood pressure in the chambers of the heart causes hemorrhage, which canlead to patient death if uninhibited blood loss occurs.

Introduction of one or more medical devices through the wall of thehollow organ and into a hollow organ is generally accomplished byplacement of a pursestring suture in the wall of the hollow organ. Anincision is then performed in the center of the pursestring suture, toallow entry of a cannula or other instrument access to the interior ofthe hollow organ. The pursestring is cinched tight around the device toprevent loss of the internal contents of the organ during performance ofthe surgical procedure in the interior of the hollow organ. At theconclusion of the procedure, the pursestring suture is cinched downcompletely, and tied to permanently close the incision in the organwall. For example, if the hollow organ is the heart, a pursestringsuture may be placed in the heart wall before making an incision toallow access to one or more chambers of the heart. The surgicalinstrument may be inserted into the heart through the incision and thepursestring may be cinched tight to maintain hemostasis and preventblood loss around the device during performance of the surgicalprocedure in the interior of the heart. After the procedure, thesurgical device may be removed and the pursestring suture may be cinchedfurther to close the incision.

Placement of the pursestring suture may be performed using a surgicalneedle holder to grasp a curved needle with the attached suture used toform the pursestring. The jaws of the needle holder grasp the curvedneedle near the central portion of its arc. Proper surgical techniquerequires insertion of the needle tip perpendicular to the surface of thetissue, followed by rotation of the needle holder to drive the needlethrough both sides of the tissue wall, which can require significantworking space adjacent the hollow organ in order to allow for movementand rotation of the needle holder. Pursestring suture placement istherefore easily performed when the hollow organ is fully exposed, forexample when the heart is completely exposed during open heart surgery.

However, pursestring suture placement is significantly more difficult,if not impossible, when the hollow organ is accessed in a manner whichdoes not significantly expose the hollow organ to the operating field,such as during minimally-invasive procedures which provide access via asmall incision in the skin. For example, if the heart is accessed via asmall suprasternal anterior neck incision, such as may be used in amediastinoscopic approach, pursestring suture placement usingconventional methods becomes very difficult. With such an approach,access to the heart from the neck incision is performed through a narrowtunnel which allows for a limited range of motion of the needle holder.The needle holder is generally positioned orthogonal to the plane of thecurved needle during suture placement. Given the constraints of theaccess method, it is nearly impossible to grasp a curved needle in theproper configuration, advance the needle down the long narrow tunnel,and place the needle through the wall of the heart located at the bottomof the tunnel, without significantly deforming the wall and potentiallycausing laceration or injury to the heart.

SUMMARY

Accordingly, there is a need for systems, methods, and devices thatenable access to an interior of a hollow organ in a minimally-invasivemanner when the access route provides limited instrumental range ofmotion. For example, when the hollow organ is a heart, access to theheart may be obtained through a small incision in the skin remote fromthe heart, via an anterior neck incision for example, and the workingarea for instrument access to the interior of the heart may be enhancedby the systems, methods, and devices described herein. There is afurther need to provide systems, methods, and devices configured tominimize the loss of the internal contents of the hollow organ, e.g.blood in the case of the heart.

Some or all of the above deficiencies and other problems associated withconventional devices and methods may be reduced or eliminated by thedisclosed devices and methods.

In accordance with some embodiments, a pursestring suture retractordevice and method is described that allows pursestring suture placementin confined and narrow anatomic situations, more specifically inmediastinoscopic access to the heart. The retractor device retracts andreshapes the wall of the heart to facilitate suture placement forinstrument access and incision closure following the surgical procedure.Deployment of the device creates opposing vertical laterally-facingwalls in the heart muscle that allows a surgical needle holder alignedaxially along the mediastinal access tunnel to easily place a curvedneedle through the heart wall to create a pursestring suture or to placeinterrupted sutures along the planned incision line. The retractordevice may also incorporate suction capability to clear the surgicalfield of blood, and it may further contain a cautery electrode to forman incision in the desired location in the retracted heart muscle.

In accordance with some embodiments, the retractor device may include atleast two elongated shafts which are coupled together so as to belongitudinally movable relative to each other. The shafts may bearranged in a parallel, concentric, or other suitable arrangement. Aninternal member is coupled to a distal end of a first shaft so as toextend therefrom in a transverse direction. A pair of external membersare coupled to a distal end of a second shaft so as to extend therefromin a direction parallel to the transverse direction. The externalmembers are spaced apart from each other, and, by moving the first shaftrelative to the second shaft, the internal member is movable relative tothe external members along a plane extending longitudinally between theexternal members.

In specific embodiments, the endoscopic tissue retraction deviceincludes a first shaft and a second shaft slidably coupled to the firstshaft and longitudinally movable relative thereto. An internal member iscoupled to the first shaft so as to extend therefrom in a transversedirection. The internal member is configured for advancement through apenetration in a target tissue of a patient. The internal members has aproximally-facing surface configured to atraumatically engage a distalsurface of the target tissue after being advanced therethrough. A pairof external members are each coupled to the second shaft so as to extendtherefrom generally parallel to the transverse direction. The externalmembers are spaced apart and each having a distally-facing surfaceconfigured to atraumatically engage a proximal surface of the targettissue. The internal member is movable longitudinally relative to theexternal members between a distal position and a proximal position alonga plane extending between the external members. The internal member isconfigured to apply traction to the target tissue when retracted fromthe distal position towards and past the pair of external members to theproximal position. The pair of external members are configured to applycounter-traction to the target tissue on opposing lateral sides of theinternal member, whereby the target tissue is re-shaped so as to have apair of laterally facing surfaces each extending between the internalmember and one of the external members.

In accordance with some embodiments, the first shaft may be rigid.

In accordance with some embodiments, the first shaft may comprise a highdurometer polymer material or metal. The first shaft may comprisepolycarbonate, liquid crystal plastic, nylon, PTFE, ABS, polypropylene,titanium, or stainless steel.

In accordance with some embodiments, the second shaft may be rigid.

In accordance with some embodiments, the second shaft may comprise ahigh durometer polymer material or metal. The second shaft may comprisepolycarbonate, liquid crystal plastic, nylon, PTFE, ABS, polypropylene,titanium, or stainless steel.

In accordance with some embodiments, the second shaft may be configuredto be inserted into a working channel of a surgical instrument, anendoscope, a mediastinoscope, or a suprasternal access device placedthrough an opening in the body of the body of the patient.

In accordance with some embodiments, the first shaft may be slidablydisposed within at least a portion of the second shaft.

In accordance with some embodiments, the internal member may be rigid.

In accordance with some embodiments, the internal member may comprisestainless steel.

In accordance with some embodiments, the target tissue may be a wall ofa heart of the patient. The internal member may be configured to beadvanced through the wall of the heart while the heart is beating.Alternatively or in combination, the internal member may be configuredto apply traction to the target tissue while the heart is beating.Alternatively or in combination, the internal member may be configuredto be advanced through the wall of the heart while a chest of thepatient remains closed. Alternatively or in combination, the internalmember may be configured to apply traction to the target tissue while achest of the patient remains closed.

In accordance with some embodiments, the internal member may beconfigured to be positioned about 1 cm proximal to the pair of externalmembers when in the proximal position.

In accordance with some embodiments, the internal member may beconfigured to be movable from a longitudinal configuration to atransverse configuration. The internal member may be configured toengage the distal surface of the target tissue when in the transverseconfiguration. Optionally, the internal member may be rotatably movablefrom the longitudinal configuration to the transverse configuration. Forexample, the internal member may be configured to be rotated from thelongitudinal configuration to the transverse configuration in responseto a force applied to the internal member in the longitudinalconfiguration.

In accordance with some embodiments, the internal member may comprise apivoting joint. The device may further comprise a rigid element coupledto the internal member and configured to apply force to the internalmember to maintain the internal member in the longitudinal configurationwhen compressed. Tensioning of the rigid element may move the rigidelements at least a first distance and may remove the force applied tothe internal member to actuate the internal member from the longitudinalconfiguration to the transverse configuration. The first distance may bewithin a range of about 1 mm to about 20 mm.

Alternatively or in combination, the device may further comprise alocking mechanism coupled to the internal member and configured tomaintain the internal member in the longitudinal configuration.Disengaging the internal member from the locking mechanism may actuatethe internal member from the longitudinal configuration to thetransverse configuration. The locking mechanism may comprise a detent ina pivoting joint of the internal member. The detent may be configured todisengage from the internal member in the longitudinal configurationwhen a force within a range of about 0.10 to about 1 pounds is appliedto the internal member. Optionally, the locking mechanism may furthercomprise a wire actuator shaped to correspond to the detent.

Alternatively or in combination, the device may further comprise alocking mechanism coupled to the internal member and configured tomaintain the internal member in the transverse configuration.Disengaging the internal member from the locking mechanism may actuatethe internal member from the transverse configuration to thelongitudinal configuration. The locking mechanism may comprise a detentin a pivoting joint of the internal member. The detent may be configuredto disengage from the internal member in the transverse configurationwhen a force within a range of about 2 to about 5 pounds is applied tothe internal member.

In accordance with some embodiments, the internal member may comprise ahollow shaft or hollow tube.

In accordance with some embodiments, the internal member may comprise atapered distal end.

In accordance with some embodiments, a distal tip of the internal membermay be tapered to sharpened to facilitate advancement through the targettissue.

In accordance with some embodiments, the internal member may comprise aguidewire lumen configured to slidably receive a guidewire therethrough.The internal member may comprise an elastomeric seal disposed within theguidewire lumen and configured to seal the target tissue and preventfluid flow through the guidewire lumen.

In accordance with some embodiments, the internal member may comprise aflare configured to contact the target tissue while the internal memberengages the distal surface of target tissue to inhibit leakage of bloodor bodily fluids.

In accordance with some embodiments, the internal member may beconfigured to apply electrocautery energy to the target tissue to make apenetration therein. The internal member may comprise an electrodecoupled thereto. Alternatively or in combination, the internal membermay comprise an electrically-conductive material.

In accordance with some embodiments, the pair of external members may berigid.

In accordance with some embodiments, the pair of external members maycomprise stainless spring steel.

In accordance with some embodiments, the pair of external members may bemoveable from a longitudinal configuration to a transverseconfiguration. The pair of external members may be configured to engagethe proximal surface of the target tissue when in the transverseconfiguration. The pair of external members may configured to be rotatedfrom the longitudinal configuration to the transverse configuration. Forexample, each of the pair of external members comprises a pivotingjoint. Alternatively or in combination, the pair of external members maybe configured to be rotated from the longitudinal configuration to thetransverse configuration in response to a force applied to the pair ofexternal members when in the longitudinal configuration.

Optionally, the device may further comprise at least two rigid elementscoupled to the pair of external members, respectively, and configured toapply force to the pair of external members to maintain the pair ofexternal members in the longitudinal configuration when compressed.Tension on the at least two rigid elements may move the at least tworigid elements at least a first distance and may remove the forceapplied to the pair of external members to actuate the pair of externalmembers from the longitudinal configuration to the transverseconfiguration. The first distance may be within a range of about 1 mm toabout 20 mm.

Alternatively or in combination, the device may further comprise atleast two locking mechanisms coupled to the pair of external members,respectively, and configured to maintain the pair of external members inthe longitudinal configuration. Disengaging the pair of external membersfrom the pair of locking mechanisms may actuate the pair of externalmembers from the longitudinal configuration to the transverseconfiguration. Each of the at least two locking mechanisms may comprisea detent in a pivoting joint of each of the pair of external members.The detent may be configured to disengage from the external member inthe straightened configuration when a force within a range of about 0.10to about 1 pounds is applied to the external member. Optionally, each ofthe at least two locking mechanisms may comprise a wire actuator shapedto correspond to the detent.

Alternatively or in combination, the device may further comprise atleast two locking mechanisms coupled to the pair of external members,respectively, and configured to maintain the pair of external members inthe transverse configuration. Disengaging the pair of external membersfrom the at least two locking mechanisms may actuate the pair ofexternal members from the transverse configuration to the longitudinalconfiguration. Each of the at least two locking mechanisms may comprisea detent in a pivoting joint of each of the pair of external members.The detent may be configured to disengage from the external member inthe transverse configuration when a force within a range of about 2 toabout 5 pounds is applied to the external member.

In accordance with some embodiments, the pair of external members maycomprise at least two wire extensions.

In accordance with some embodiments, the first shaft may be configuredto translate relative to the second shaft. Translation of the firstshaft relative to the second shaft may actuate the internal member fromthe distal position to the proximal position. Optionally, the secondshaft may comprise at least two slots disposed in opposing walls of aproximal end of the second shaft and the first shaft may comprise acrossbar configured to extend through the at least two slots.Translation of the crossbar within the slots may translate the firstshaft relative to the second shaft.

In accordance with some embodiments, the first shaft may comprise asuction lumen configured to remove blood or bodily fluids from thetarget tissue. Optionally, the suction lumen may be configured to befluidly coupled to a negative pressure source.

In accordance with some embodiments, a system includes any of thedevices described herein and a guidewire slidably disposed in a lumen ofthe internal member. Optionally, the internal member may be configuredto be advanced through the target tissue over the guidewire.

In accordance with some embodiments, a system includes any of thedevices described herein, one or more sutures, and a curved needlecoupled to the one or more sutures and configured to place the one ormore sutures in the target tissue when the internal member appliestraction to the target tissue. The curved needle may configured to placethe one or more sutures in the target tissue as a pursestring suture.Alternatively or in combination, the curved needle may be configured toplace the one or more sutures in the target tissue as a plurality ofinterrupted sutures.

In accordance with some embodiments, a system includes any of thedevices described herein and a visualization device. The visualizationdevice may comprise a mediastinoscope, a camera coupled to a distalportion of the endoscopic tissue retraction device, an optical channelin the endoscopic tissue retraction device, or an endoscope.

In accordance with some embodiments, a method of placing a suture in atissue of a patient includes inserting an endoscopic tissue retractiondevice into a body of a patient and advancing a distal portion of theendoscopic tissue retraction device toward a target tissue of thepatient, the distal portion comprising an internal member and a pair ofspaced-apart external members, the internal member being longitudinallymovable relative to the pair of external members along a plane extendingbetween the pair of external members. The method further includesadvancing the internal member of the tissue retraction device throughthe target tissue to engage a distal surface of the target tissue andapplying traction to the target tissue with the internal member byretracting the internal member from a distal position towards and pastthe pair of external members to a proximal position while engaging aproximal surface of the target tissue with the pair of external members.The pair of external members are configured to apply counter-traction onopposing lateral sides of the internal member, wherein the target tissueis re-shaped so as to have a pair of laterally facing surfaces eachextending between the internal member and one of the external members.The method further includes placing one or more sutures in at least oneof the laterally facing surfaces of the target tissue while the internalmember and the pair of external members apply traction thereto.

In accordance with some embodiments, the method may further comprisemaking an incision in the target tissue within the one or more sutures.Making the incision may comprise applying electrocautery energy to thetarget tissue with the internal member. Alternatively or in combination,making the incision may comprise cutting the target tissue with a blade.Alternatively or in combination, making the incision may compriseadvancing a cardiovascular sheath and dilator through the target tissueand dilating the target tissue with the dilator.

In accordance with some embodiments, the method may further compriseclosing the incision by tightening or knotting the one or more suturesaround the incision. Placing one or more sutures in the target tissuemay comprise placing a pursestring suture and tightening the one or moresutures may comprise cinching the pursetring suture. Alternatively or incombination, placing one or more sutures in the target tissue maycomprise placing a plurality of interrupted sutures and knotting the oneor more sutures may comprise knotting the plurality of interruptedsutures.

In accordance with some embodiments, the method may further compriseinserting a distal portion of a surgical instrument through theincision. The method may further comprise sealing the incision aroundthe surgical instrument to inhibit leakage of blood or bodily fluids.Sealing the incision around the surgical instrument may comprisetightening or knotting the one or more sutures around the incision.

In accordance with some embodiments, the method may further compriseremoving the distal portion of the surgical instrument from the incisionand closing the incision after removing the distal portion of thesurgical instrument by tightening or knotting the one or more suturesaround the incision. Placing one or more sutures in the target tissuemay comprise placing a pursestring suture and tightening the one or moresutures may comprise cinching the pursetring suture. Alternatively or incombination, placing one or more sutures in the target tissue maycomprise placing a plurality of interrupted sutures and knotting the oneor more sutures may comprise knotting the plurality of interruptedsutures.

In accordance with some embodiments, the method may further compriseperforming a surgical procedure with the surgical instrument after thesurgical instrument is inserted through the incision. The target tissuemay comprise a wall of a heart of the patient and wherein the surgicalprocedure comprises at least one of mitral valve replacement, mitralvalve repair, mitral annuloplasty, chordal repair, chordal replacement,leaflet resection, or leaflet coaptation. Alternatively or incombination, the target tissue may comprise a wall of a heart of thepatient and wherein the surgical procedure comprises at least one ofatrial appendage closure, atrial ablation, pulmonary vein ablation,septal defect closure, aortic valve repair, aortic valve replacement,tricuspid valve repair, tricuspid valve replacement, implantable cardiacdefibrillator (ICD) implantation, pacemaker implantation, or placementof leads for ICD's or pacemakers, myocardial biopsy, or septectomy.

In accordance with some embodiments, the target tissue may comprise awall of a heart of the patient. In some embodiments, the heart mayremain beating during the steps of inserting the endoscopic tissueretraction device, advancing the distal portion, advancing the internalmember, applying traction, and placing the one or more sutures.Alternatively or in combination, a chest of the patient may remainclosed during the steps of inserting the endoscopic tissue retractiondevice, advancing the distal portion, advancing the internal member,applying traction, and placing the one or more sutures.

In accordance with some embodiments, placing the one or more sutures maycomprise placing a pursestring suture. Alternatively or in combination,placing the one or more sutures may comprise placing a plurality ofinterrupted sutures.

In accordance with some embodiments, advancing the internal member maybe configured to create a penetration in the target tissue through whichit is advanced. Optionally, the method may further comprise deliveringelectrocautery energy to the target tissue from the internal member tocreate the penetration.

In accordance with some embodiments, the method may further comprisemoving the internal member from a longitudinal configuration to atransverse configuration after it is advanced through the target tissue.Moving the internal member from the longitudinal configuration to thetransverse configuration may comprise rotating the internal member fromthe longitudinal configuration to the transverse configuration. Rotatingthe internal member may comprise applying force to the internal memberin the longitudinal configuration.

In accordance with some embodiments, the endoscopic tissue retractiondevice may comprise a rigid element coupled to the internal member andconfigured to apply force to the internal member to maintain theinternal member in the longitudinal configuration when compressed.Moving the internal member may comprise tensioning the rigid element toremove the force applied to the internal member.

Alternatively or in combination, the endoscopic tissue retraction devicemay comprise a locking mechanism coupled to the internal member andconfigured to maintain the internal member in the longitudinalconfiguration. Moving the internal member may comprise disengaging theinternal member from the locking mechanism.

In accordance with some embodiments, the method may further comprisemoving the pair of external members from a longitudinal configuration toa transverse configuration. Moving the pair of external members from thelongitudinal configuration to the transverse configuration may compriserotating the two or more external members from the longitudinalconfiguration to the transverse configuration. Rotating the pair ofexternal members may comprise applying force to the pair of externalmembers in the longitudinal configuration.

In accordance with some embodiments, the endoscopic tissue retractiondevice may comprise two or more rigid elements coupled to the pair ofexternal members, respectively, and configured to apply force to thepair of external members to maintain the pair of external members in thelongitudinal configuration when compressed. Moving the pair of externalmembers may comprise tensioning the two or more rigid elements to removethe force applied to the pair of external members.

Alternatively or in combination, the endoscopic tissue retraction devicemay comprise two or more locking mechanisms coupled to the pair ofexternal members and configured to maintain the pair of external membersin the longitudinal configuration. Moving the pair of external membersmay comprise disengaging the pair of external members from the two ormore locking mechanisms.

In accordance with some embodiments, inserting the endoscopic tissueretraction device into the body of the patient may comprise insertingthe endoscopic tissue retraction device in a working channel of asurgical instrument, an endo scope, a mediastinoscope, or a suprasternalaccess device placed through an opening in the body of the body of thepatient.

In accordance with some embodiments, the method may further comprisesealing the target tissue with the internal member while it engages thedistal surface of the target tissue to inhibit leakage of blood orbodily fluids. The method may further comprise sealing the penetrationwith a flared portion of the internal member while the internal memberengages the distal surface of target tissue. Alternatively or incombination, the internal member may comprise a lumen and an elastomericseal disposed therein, the elastomeric seal being configured to inhibitflow through the lumen.

In accordance with some embodiments, the method may further compriseinserting a guidewire through the target tissue before advancing theinternal member therethrough. Advancing the internal member through thetarget tissue may comprise slidably advancing the internal member overthe guidewire, the guidewire being disposed in a lumen of the internalmember. The method may further comprise removing the internal memberfrom the target tissue after the sutures are placed. Optionally, theinternal member may be slidably removed over the guidewire. In someembodiments, the guidewire may remain through the target tissue afterthe internal member is removed.

In accordance with some embodiments, the endoscopic tissue retractiondevice may comprise a first shaft coupled to the internal member and asecond shaft slidably coupled to the first shaft, the second shaft beingcoupled to the two or more external members. Retracting the internalmember from the distal position to the proximal position may comprisetranslating the first shaft relative to the second shaft.

In accordance with some embodiments, the method may further comprisesuctioning blood or bodily fluids from the target tissue through asuction lumen in the endoscopic tissue retraction device.

In accordance with some embodiments, the method may further comprisevisualizing the target tissue while inserting the endoscopic tissueretraction device, advancing the distal portion, advancing the internalmember, applying traction, placing the one or more sutures, or makingthe incision. Visualizing may comprise viewing the target tissue with amediastinoscope, a camera coupled to the distal portion of theendoscopic tissue retraction device, an optical channel in theendoscopic tissue retraction device, or an endoscope.

In accordance with some embodiments, the target tissue may comprise aroof of the left atrium. The distal portion of the endoscopic tissueretraction device may be advanced to the roof of the left atrium from apenetration at a suprasternal access site while the sternum and ribs ofthe patient remain intact. Alternatively or in combination, the internalmember may be advanced through the target tissue without penetrating orcutting a pericardium of the heart.

In specific embodiments, the retractor device includes a rigid outertube with two external members, for example wire extensions,perpendicularly attached to the outer distal end of the tube, and arigid inner tube that translates within the outer tube. An internalmember with a tapered distal end may be perpendicularly attached to thedistal end of the inner tube, and the tube may be configured to flareout at its attachment point to the inner tube. An elastomeric seal maybe present at the proximal end of the inner lumen of the taperedinternal member to seal against blood loss when a guidewire lies insidethe tube, and upon removal of the guidewire. The tapered distal end ofthe internal member, also referred to as a perpendicularly attachedtube, may allow it to be advanced along a guidewire, inserted moreeasily into a needle puncture site, and to dilate the puncture sitewhile maintaining a hemostatic seal as the third tube is insertedthrough an outer wall of a heart and into the left atrium. The flare atthe attachment point of the third tube to the inner tube further ensuresthat the internal member creates a seal at the puncture site, minimizingor eliminating bleeding during heart wall retraction.

In accordance with some embodiments, slots may be present in opposingwalls of the proximal outer tube, and a crossbar may extend throughthese slots and attach to the inner tube. The crossbar may be used as acontrol actuator for translation of the inner tube with respect to theouter tube, and it may also serve to key the inner tube with the outertube to prevent relative rotation between the two. The slots may bepositioned so that upon full extension of the inner tube, the internalmember with a tapered end lies approximately 1 cm distal to the two wireextensions on the outer tube; and upon full proximal retraction, theattached internal member on the inner tube lies approximately 1 cmproximal to the two wire extensions on the outer tube. An open channelmay extend from the distal end of the inner tube to one side of thecrossbar, and a vacuum tube may be attached to that side of the crossbarto allow suction to be performed by the inner tube. An insulatedconductive electrode may extends down the inner tube and connect to theinternal member, allowing electrocautery energy to be applied to theinternal member to create an incision line in a heart wall, an atrialwall for example. The outer surface of the inner tube may be coated witha non-conductive material to avoid unintentional energy conduction totissue outside of the incision line.

In accordance with some embodiments, the retractor device may beparticularly useful in a mediastinoscopic approach to access and operateinside the left atrium of the heart, to repair the mitral valve forexample. To expose the left atrium from a mediastinoscopic approach, a6-8 cm incision may be performed in the anterior neck superior to thesternal notch, and blunt dissection may be conducted anterior to thetrachea. The dissection plane may be advanced inferiorly to expose thepulmonary veins and the dome of the left atrium. These structures lieposterior to the pulmonary artery. The mediastinoscope may contain anendoscope for visualization of internal structures on a video monitor,and an elongated curved retraction blade, to maintain an operatingtunnel that extends from the neck incision inferiorly to the dome of theleft atrium.

In accordance with some embodiments, after the mediastinoscope has beenadvanced into position to expose the heart, a long needle may beadvanced down the working tunnel and inserted into the dome of the leftatrium. Bright red, oxygenated blood exiting the proximal hub of theneedle indicates that the needle has entered the left atrium, and notthe pulmonary artery that carries dark, un-oxygenated blood. A guidewiremay be advanced through the needle into the left atrium, and the needlemay then be removed. The tapered end of the internal member of theretractor device may be loaded onto the guidewire outside the patient'sbody, advanced through the mediastinal tunnel, and inserted through theneedle puncture site into the left atrium. The guidewire may then beremoved, the elastomeric seal maintaining hemostasis after guidewireremoval. During the insertion maneuver, the two wire extensions attachedto the outer tube may be situated above the surface of the left atrium.Upon actuation of the crossbar, the internal member inside the leftatrium may be retracted 1 cm above the two wire extensions, therebyforming a tent in the atrial wall. The vertical laterally-facing wallsof the tented atrium facilitate placement of a pursestring suture deepin the mediastinum, as the long axis of the needle holder is collinearwith the bore of the operating cavity. The tip of the curved needle iseasily placed perpendicular to the vertical wall of the atrial tent, andaxial rotation of the needle holder is likewise easily performed toplace a pursestring stitch. Upon completion of a pursestring suture, theguidewire may be reinserted through the retractor into the left atrium,the retractor removed, and a standard cardiovascular sheath and dilatoradvanced along the guidewire to provide access into the heart. The freeends of the suture may be pulled through a length of polymer tubing tocinch the pursestring around the cardiovascular sheath, and a surgicalclamp placed on the outside of the polymer tube with its indwellingsutures, forming what is commonly known as a Rumel tourniquet. Uponcompletion of the surgical procedure, the polymer tube is removed, andthe suture ends tied to permanently close the pursestring.

In accordance with some embodiments, if a larger incision is desired inthe atrial wall, instead of cardiovascular sheath placement,electrocautery energy may be applied the internal member, causingincision of the atrial wall along a part of, or all of, the length ofthe internal member. Alternatively, a scalpel blade may be used toincise the atrial wall, with the intracardiac tubular structure actingas a backstop inside the heart, to avoid injury to intracardiacstructures upon performance of the incision. Direct scalpel incisionavoids creation of tissue char that occurs during electrocautery use,and this may be preferred by some surgeons. The retractor device mayalso be used to assist in the placement of a series of interruptedsutures, rather than a pursestring suture. Multiple curved needle armedsutures may be placed through both walls of the atrial tent, and theends of the suture externalized, or brought out of the body via the neckincision. The individual sutures are tied to close the incision at theend of the procedure.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the disclosure are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present disclosure will be obtained by reference tothe following detailed description that sets forth illustrativeembodiments, in which the principles of the disclosure are utilized, andthe accompanying drawings of which:

FIG. 1 shows a mediastinoscope inserted via a neck incision to accessthe heart.

FIGS. 2A-2B show the cylindrical shaped boundary of the working tunnelprovided by a mediastinoscopic approach to the heart.

FIGS. 3A-3C show the steps in the placement of a pursestring sutureusing conventional techniques.

FIG. 4 shows the required orientation of a surgical needle holder duringplacement of a pursestring suture using conventional techniques.

FIG. 5 shows that the required orientation of a needle holder duringexecution of a pursestring suture using conventional techniques lies faroutside the boundary of the working tunnel that exists withmediastinoscopy.

FIGS. 6A-6D show various views of an endoscopic pursestring sutureretractor. FIG. 6A shows a front view of the endoscopic retractor. FIG.6B shows a side view of the endoscopic retractor. FIG. 6C shows aposterior view of the endoscopic retractor. FIG. 6D shows a tapereddistal end of the endoscopic retractor.

FIG. 7A shows an endoscopic retractor comprising an internal member andtwo external members in a longitudinal configuration.

FIG. 7B shows the endoscopic retractor of FIG. 7A with the internal andexternal members in a transverse configuration.

FIGS. 8A-8B show a mechanism for actuating the internal member and/orexternal members between a longitudinal configuration and a transverseconfiguration.

FIGS. 9A-9B show another mechanism for actuating the internal memberand/or external members between a longitudinal configuration and atransverse configuration.

FIGS. 10A-10B show yet another mechanism for actuating the internalmember and/or external members between a longitudinal configuration anda transverse configuration.

FIG. 11A shows an endoscopic pursestring suture retractor comprising aninternal member in a distal configuration below two external members.

FIG. 11B shows an endoscopic pursestring suture retractor of FIG. 11Awith the internal member in a proximal configuration above two externalmembers.

FIGS. 12A-12C demonstrate the mechanism of retraction of the atrial wallusing an endoscopic pursestring suture retractor.

FIG. 13 shows the configuration of the curved needle and the surgicalneedle holder when used with an endoscopic pursestring suture retractor.

FIGS. 14A-14E show placement of an endoscopic pursestring sutureretractor into the left atrium of the heart. FIGS. 14A-14C showplacement of a guidewire into the left atrium of the heart via a needle.FIG. 14D shows an endoscopic pursestring suture retractor loaded ontothe guidewire following needle removal. FIG. 14E shows advancement ofthe endoscopic pursestring suture retractor along the guidewire into theleft atrium of the heart.

FIG. 15 shows a surgical instrument inserted through an incision in thecenter of a pursestring suture placed with the help of an endoscopicretractor.

FIG. 16 shows cinching of pursestring suture to close the left atrialincision following removal of a surgical instrument from the heart.

FIG. 17 shows placement of interrupted sutures in the left atrium usingan endoscopic pursestring suture retractor.

FIG. 18A shows placement of interrupted sutures around an incision inthe left atrium.

FIG. 18B shows the configuration of interrupted sutures used to close aleft atrial incision.

DETAILED DESCRIPTION

Reference will now be made in detail to implementations, examples ofwhich are illustrated in the accompanying drawings. In the followingdetailed description, numerous specific details are set forth in orderto provide a thorough understanding of the various describedimplementations. However, it will be apparent to one of ordinary skillin the art that the various described implementations may be practicedwithout these specific details. In other instances, well-known methods,procedures, components, circuits, and networks have not been describedin detail so as not to unnecessarily obscure aspects of theimplementations.

Many modifications and variations of this disclosure can be made withoutdeparting from its spirit and scope, as will be apparent to thoseskilled in the art. The specific implementations described herein areoffered by way of example only, and the disclosure is to be limited onlyby the terms of the appended claims, along with the full scope ofequivalents to which such claims are entitled. It will be readilyunderstood that the aspects of the present disclosure, as generallydescribed herein, and illustrated in the figures, can be arranged,substituted, combined, separated, and designed in a wide variety ofdifferent configurations, all of which are explicitly contemplatedherein.

Although certain embodiments and examples are disclosed below, inventivesubject matter extends beyond the specifically disclosed embodiments toother alternative embodiments and/or uses, and to modifications andequivalents thereof. Thus, the scope of the claims appended hereto isnot limited by any of the particular embodiments described below. Forexample, in any method or process disclosed herein, the acts oroperations of the method or process may be performed in any suitablesequence and are not necessarily limited to any particular disclosedsequence. Various operations may be described as multiple discreteoperations in turn, in a manner that may be helpful in understandingcertain embodiments, however, the order of description should not beconstrued to imply that these operations are order dependent.Additionally, the structures, systems, and/or devices described hereinmay be embodied as integrated components or as separate components.

For purposes of comparing various embodiments, certain aspects andadvantages of these embodiments are described. Not necessarily all suchaspects or advantages are achieved by any particular embodiment. Thus,for example, various embodiments may be carried out in a manner thatachieves or optimizes one advantage or group of advantages as taughtherein without necessarily achieving other aspects or advantages as mayalso be taught or suggested herein.

The present disclosure will be described in relation to the deploymentof the device for retraction of an atrial wall of the heart to aid inthe placement of one or more sutures therein. However, one of skill inthe art will appreciate that this is not intended to be limiting and thedevices and methods disclosed herein may be used in other anatomicalareas to access other hollow organs or biological structures and inother surgical procedures. Anatomical areas may, for example, includethe thoracic cavity, the abdominal cavity, the neck, the back or spine,or any other anatomical area known to one of ordinary skill in the art.Hollow organs or biological structures may, for example, include theheart, the stomach, the colon, the small intestine, the bladder, thegallbladder, the bile ducts, the fallopian tubes, the ureters, theappendix, or any other hollow organ known to one of ordinary skill inthe art. Procedures may, for example, include mitral valve replacementor repair, mitral annuloplasty, chordal repair or replacement, coronaryartery bypass grafting, colorectal surgery, small intestine surgery,bariatric surgery, stomach surgery, or other surgical procedures whichmay leave require an incision for access into a hollow organ and wouldbenefit from a minimally-invasive device and method for retractingtissue for placement of sutures around the incision.

As a non-limiting example, reference will now be made to the use of anendoscopic tissue retraction device for performing reconfiguration ofthe left atrial wall to facilitate the placement of a pursestring suturein a tight space remote from the entry incision site. For example, theentrance incision may be in the neck of a patient, such as in thesuprasternal notch, which may allow for access to the left atrial wallvia a path through the mediastinal space of the body. Such a path may besubstantially similar to that travelled by a mediastinoscope or othersuprasternal access device and may provide direct access to the top ofthe heart with minimal injury to the patient compared to open heartsurgical methods which often require cutting a bone (such as thesternum, manubrium, or a rib) and/or the thoracic diaphragm, orspreading the ribs, thereby avoiding the complications associated withsuch injuries. Specific reference is made herein to accessing a targettissue comprising a roof of the left atrium. The endoscopic tissueretraction device may be advanced through the roof of the left atriumvia a penetration at a suprasternal access site as described hereinwithout injuring or altering the ribs and/or sternum of the patient. Theendoscopic tissue retraction device may be advanced through the roof ofthe left atrium without penetrating or cutting a pericardium of theheart.

FIG. 1 illustrates the configuration of a conventional mediastinoscope10 placed through a neck incision 11, and positioned above the leftatrium of the heart. The neck incision 11 may lie superior to oradjacent the sternal notch 12. The suprasternal notch 12 is a generallytriangular gap between the collar bones of the patient where the tissueis free from underlying bone. The incision location 11 may be within,above, or through the triangular gap of the suprasternal notch 12. Themediastinoscope 10 may be inserted through the incision 11 in thesuprasternal notch 12 and advanced into the body of the patient alongthe trachea 13 in the anatomical plane anterior to the trachea 13 andposterior to the arch of the aorta 14 through a mediastinal space of thebody toward the left atrium of the heart.

FIG. 2A shows a posterior view of a heart 15 with the left inferiorpulmonary vein 16 depicted for orientation. The roof of the left atrium15, which lies in the center of the area bounded by the pulmonary veinsand does not comprise a pericardium, may be the target entry point intothe left atrium 15 for a surgical procedure, for example using amediastinoscope or a suprasternal access device as described inPCT/US2018/042171, the entire contents of which are incorporated hereinby reference. FIG. 2B shows a cylindrically-shaped boundary of theworking area 17 provided by a mediastinoscopic or suprasternal approachto the left atrium heart 15. By introducing a surgical instrument intothe patient via the suprasternal notch, the roof of the left atrium 15may be accessed without cutting bone or causing injury to other internalstructures of the patient as described herein. However, compared to openheart access, the available working space 17 available with asuprasternal approach may provide a more limited instrumental range ofmotion within which to work. This open access area 17 may be surroundedby anatomical structures which would be deleterious to disrupt, thussurgical instrument access may be limited to the area defined by the topof the cylinder 17.

FIGS. 3A-3C show the steps of placing a pursestring suture 20 pattern inthe left atrium 15 using a conventional technique. A suture 18 attachedto a curved needle 19 may be used to place the pursestring suture 20 inthe tissue wall. Proper suturing technique requires that the distal tipof the curved needle 19 be inserted into the target tissue, the leftatrium 15, perpendicularly through the wall of the left atrium 15, asshown in FIG. 3A. Next, the curved needle 19 is rotated so as toincorporate a section of the target tissue, as shown in FIG. 3B.Multiple bites of tissue are performed in a roughly circular pattern toform the pursestring suture 20, as shown in FIG. 3C. A surgical needleholder (such as needle holder 21 shown in FIG. 4) may be used to graspand manipulate the curved needle 19 to form the pursestring suture 20.

FIG. 4 shows a surgical needle holder 21 grasping a curved needle 19during placement of a pursestring suture in the left atrium 15. Thesurgical needle holder 21 is shown grasping the central portion of thecurved needle 19 to manipulate the curved needle 19 during sutureplacement. The surgical needle holder 21 is typically orientedorthogonally to the central portion of the curved needle 19 when placingthe suture. In order to insert the curved needle 19 perpendicular to thesurface of the left atrium 15, as shown in FIG. 3A, and to rotate thecurved needle 19 to place a stitch during execution of the pursestringsuture as shown in FIG. 3B, the surgical needle holder 21 is thusoriented relatively parallel to the tissue surface using conventionaltechniques.

FIG. 5 shows that the required orientation of a needle holder 21 duringexecution of a pursestring suture 20 using conventional techniques liesfar outside the boundary of the working tunnel 17 that exists whenaccessing the roof of the left atrium 15 via a mediastinoscopic orsuprasternal approach path. The typical open surgical positioning of theneedle holder 21 used to place a pursestring suture 20 in the leftatrium 15, as shown in FIG. 4, places the handle of the needle holder 21far outside the working space 17 available for such an approach. Thereis therefore a need for devices, systems, and methods to facilitatepursestring suture 20 placement when the available working space 17 doesnot provide for full range of motion of a needle holder 21 as would beavailable with more invasive access pathways.

FIGS. 6A-6D show various views of an endoscopic pursestring sutureretractor 22. FIG. 6A shows a front view of the endoscopic retractiondevice 22. FIG. 6B shows a side view of the endoscopic retractiondevice. FIG. 6C shows a posterior view of the endoscopic retractiondevice 22. FIG. 6D shows a tapered distal end 26 of the endoscopicretraction device 22.

The endoscopic tissue retraction device 22 may comprise a first shaft 25and a second shaft 23 slidably coupled thereto. The second shaft 23 maybe longitudinally movable relative to the first shaft 25. Accordingly,the first shaft 25 may be longitudinally movable relative to the secondshaft 23. In some embodiments, at least a portion of first shaft 25 maybe slidably disposed within a lumen of the second shaft 23 as shown suchthat it translates longitudinally therein. Alternatively or incombination, at least a portion of the first shaft 25 may be slidablycoupled adjacent the second shaft 23, for example in a side-by-sidemanner. An internal member 26 may be coupled to the first shaft 25 so asto extend therefrom in a transverse or perpendicular direction relativeto a longitudinal axis of the first shaft 25 (as highlighted in FIG.6B). A pair of external members 24 may each be coupled to the secondshaft 23 so as to extend therefrom relatively parallel to the transversedirection of the internal member 26 (as highlighted in FIG. 6B). Thepair of external members 24 may be spaced apart from one another and maylie in a plane disposed transverse to the longitudinal axis of the firstand second shafts. In alternative embodiments, not shown, in place ofsecond shaft 23, two separate shafts may be provided, and each externalmember 24 may be coupled to an individual shaft which is movablerelative to the first shaft. Further, more than two external members 24may be provided, all coupled to one shaft or each coupled to a separateshaft.

The internal member 26 may be configured to be advanced through apenetration in a target tissue into the interior of the hollow organ(e.g. the heart) as described herein. The internal member 26 maycomprise a proximally-facing surface configured to atraumatically engagea distal surface of the target tissue after being advanced therethrough.The pair of external members 24 may remain outside the hollow organ whenthe internal member 26 is advanced therein. The pair of external members24 may each have a distally-facing surface configured to atraumaticallyengage a proximal surface of the target tissue.

The internal member 26 may comprise a tapered distal end 26E. The distalend 26E may be tapered or sharpened to facilitate advancement of theinternal member 26 through a target tissue as described herein. Thetapered distal end 26E of the internal member 26 may allow it to beadvanced along a guidewire as described herein, inserted more easilyinto a needle puncture site, and dilate the puncture site whilemaintaining a hemostatic seal as the internal member 26 is insertedthrough an outer wall of a heart and into the left atrium. All or adistal portion of internal member 26 may optionally be conductive andconfigured to deliver electrocautery energy to facilitate penetration ofthe target tissue, as further described below.

The internal member 26 may comprise a flare or flared portion 27configured to contact the target tissue while the internal member 26engages the distal surface of the target tissue to inhibit leakage ofblood, bodily fluids, or other internal contents of the hollow organ.The flare 27 may be located in a proximal region of internal member 26,at or near the attachment point of the internal member 26 to the firstshaft 25. When the internal member 26 is inserted into the heart wall,for example, while the heart is beating, the flare may seal the puncturesite in the heart tissue such that no bleeding occurs during retractionof the heart wall.

In some embodiments, the internal member 26 may comprise a lumen 29 asshown in FIG. 6D. The lumen 29 may be configured to slidably receive aguidewire therethrough (for example as shown in FIGS. 14D-14E). Anelastomeric seal 28 may be disposed with the guidewire lumen 29 as shownin FIGS. 6C-6D. The elastomeric seal 28 may, for example, be positionedat a proximal end of the lumen 29. The elastomeric seal 28 may beconfigured to seal the target tissue when the internal member 26 isdisposed therein and prevent fluid (e.g. blood or other bodily fluid)flow through the lumen 29. The elastomeric seal 28 may be configured toprevent fluid loss from the hollow organ when a guidewire is presentinside the internal member 26 and when the lumen 29 is empty afterremoval of the guidewire.

The internal member 26 may be movable longitudinally relative to thepair of external members 24 between a distal position and a proximalposition along a plane longitudinally extending between the externalmembers 26 as described herein. When retracted from the distal position,past the pair of external members 24, to the proximal positon (forexample as shown in FIGS. 11A-11B), the internal member 26 may applytraction to the target tissue. The pair of external members 24 may applycounter-traction to the target tissue on opposing lateral sides of theinternal member 26. The traction and counter-traction applied to thetarget tissue may re-shape the target tissue such that it is foldedaround the internal member 26 into two generally vertical portions eachhaving a laterally-facing surface, each extending between the internalmember 26 and one of the external members 24 (for example as shown inFIGS. 12B-12C). The laterally-facing surfaces may allow for sutureplacement, for example pursestring suture placement, for instrumentaccess to and incision closure in a hollow organ in confined and narrowanatomic situations as described herein.

The first shaft 25 may be configured to translate relative to the secondshaft 23 as described herein. Translation of the first shaft 25 relativeto the second shaft 23 may actuate the internal member 26 from thedistal position to the proximal position. The shafts 23, 25 may bearranged in a parallel, concentric, or other suitable arrangement.

In some embodiments, the first shaft 25 may be slidably disposed withinat least a portion of the second shaft 23. The second shaft 23 maycomprise at least two slots 23S disposed in opposing walls of theproximal end of the second shaft 23. The first shaft 25 may comprise acrossbar 30 configured to extend through the slots 23S. The crossbar 30may act as the control actuator for translation of first shaft 25 withrespect to the second shaft 23. Translation of the crossbar 30 withinthe slots 23S may translate the first shaft 25 relative to the secondshaft 23 as described herein. Alternatively or in combination, thecrossbar 30 may serve to key the first shaft 25 with the second shaft 23to prevent relative rotation between the two. It will be understood byone of ordinary skill in the art that crossbar 30 and slots 23S areexemplary and are not meant to be limiting. Crossbar 30 may besubstituted by any other type known in the art to control longitudinaltranslation of the first shaft 25 with respect to the second shaft 23,including but not limited to a rail and guide combination, frictionwheel(s), electric or magnetic motor, electrically contract Nitinol®wire, and the like.

The first shaft 25 may comprise a suction lumen or open channel 31configured to remove blood or other bodily fluids from the target tissueand the surgical field during a procedure. The suction lumen may extendfrom the distal end of the first shaft 25 to one side of the crossbar30. The suction lumen 31 may be fluidly coupled to a negative pressuresource, for example via a vacuum line 32 attached to the crossbar 30.

The internal member 26 may be configured to apply electrocautery energyto the target tissue to make a penetration or incision therein asdescribed herein. The internal member 26 may be configured to create anincision in the target tissue along at least a portion of the length ofthe internal member 26. The internal member 26 may for example comprisean electrode. Alternatively or in combination, the internal member 26may comprise, or may be conductively coupled to, an electrode 33E. Theelectrode 33E may comprise all or a portion of internal member 26, or itmay comprise a separate electrode element attached to internal member26. In some embodiments, a portion of internal member 26 may be coveredwith an electrically insulating material, leaving a selected portionexposed to deliver energy to tissue. A wire 33 may extend from thecrossbar 30 down the first shaft 25 and connect to the internal member26, allowing electrocautery energy to be applied to a portion of theinternal member 26 to create an incision in the wall of the targettissue. The outer surface of first shaft 25 may be coated with anon-conductive material to avoid unintentional energy conduction totissue outside of the incision line.

The internal member 26 may be coupled to the first shaft 25 at a distalend thereof. In some embodiments, the internal member 26 may comprisethe distal end of the first shaft 25. In some embodiments, the internalmember 26 may comprise a hollow tube or hollow shaft.

The pair of external members 24 may be coupled to the second shaft 23 ata distal end thereof. In some embodiments, the pair external members 24may comprise the distal end of the second shaft 23. In some embodiments,the pair of external members 24 may comprise at least two wireextensions.

In some instances, at least a portion of the first shaft 25 may berigid. For example, the entire length of first shaft 25 may be rigid.Alternatively, a distal portion of the first shaft 25 and/or a proximalportion and/or any portions therebetween may be rigid. The first shaft25 may, for example, comprise a rigid tube or rigid solid shaft.

The first shaft 25 may be constructed of a material comprising a highdurometer polymer such as polycarbonate, liquid crystal plastic, nylon,PTFE, ABS, polypropylene, or the like. Alternatively or in combination,the first shaft 25 may be constructed of a material comprising a metalsuch as stainless steel, titanium, or the like.

In some instances, at least a portion of the second shaft 23 may berigid. For example, the entire length of second shaft 23 may be rigid.Alternatively, a distal portion of the second shaft 23 and/or a proximalportion and/or any portions therebetween may be rigid. The second shaft23 may, for example, comprise a rigid tube, rigid hollow shaft. In someembodiments, for example when at least a portion of the first shaft 25and second shaft 23 are disposed adjacent one another (instead ofcoaxial) the second shaft 23 may comprise a rigid solid shaft.

The second shaft 23 may be constructed of a material comprising a highdurometer polymer such as polycarbonate, liquid crystal plastic, nylon,PTFE, ABS, polypropylene, or the like. Alternatively or in combination,the second shaft 23 may be constructed of a material comprising a metalsuch as stainless steel, titanium, or the like.

The second shaft 23 may be configured to be inserted into a workingchannel of a surgical instrument, an endoscope, a mediastinoscope, or asuprasternal access device, or the like placed through an opening in thebody of the patient. For example, the second shaft 23 may be configuredto be inserted into a working channel of a mediastinoscope or asuprasternal access device placed through an opening adjacent thesuprasternal notch of the patient in order to access the roof of theleft atrium of the heart.

In some instances, at least a portion of the internal member 26 may berigid. For example, the entire length of the internal member 26 may berigid. Alternatively, a distal portion of the internal member 26 and/ora proximal portion and/or any portions therebetween may be rigid. Theinternal member 26 may, for example, comprise a rigid tube or rigidsolid shaft. The internal member 26 may comprise a rigid hollow tube orrigid hollow shaft.

The internal member 26 may be constructed of a material comprising ahigh durometer polymer such as polycarbonate, liquid crystal plastic,nylon, PTFE, ABS, polypropylene, or the like. Alternatively or incombination, the internal member 26 may be constructed of a materialcomprising a metal such as stainless steel, titanium, or the like.

In some instances, at least a portion of one or both of the pair ofexternal members 24 may be rigid. For example, the entire length of oneor both of the pair of external members 24 may be rigid. Alternatively,a distal portion of the internal member 26 and/or a proximal portionand/or any portions therebetween one or both of the pair of externalmembers 24 may be rigid. One or both of the pair of external members 24may, for example, comprise a rigid wire extension

One or both of the pair of external members 24 may be constructed of amaterial comprising a high durometer polymer such as polycarbonate,liquid crystal plastic, nylon, PTFE, ABS, polypropylene, or the like.Alternatively or in combination, one or both of the pair of externalmembers 24 may be constructed of a material comprising a metal such asstainless spring steel, titanium, or the like.

FIGS. 7A-7B show an endoscopic retraction device 22 comprising aninternal member 26 and a pair of external members 24. The retractiondevice 22 may be substantially similar to the retraction device shown inFIGS. 6A-6D, with the exception that one or more of the internal member26 and/or one or both of the pair of external members 24 may beconfigured to be movable from a longitudinal configuration to atransverse configuration. FIG. 7A shows the endoscopic retractor 22 withthe internal member 26 and the external members 24 in the longitudinalconfiguration. FIG. 7B shows the endoscopic retractor 22 with theinternal member 26 and external members 24 in the transverseconfiguration. The internal member 26 and/or external members 24 may beadvanced through the working space of the access pathway to the targettissue in the longitudinal configuration before being moved into thetransverse configuration adjacent the target tissue. For example, theinternal member 26 and/or external members 24 may be moved into thetransverse configuration before or after the internal member 26 isadvanced through the target tissue into the hollow organ as describedherein. The internal member 26 may be configured to engage the distalsurface of the target tissue when in the transverse configuration asdescribed herein. The external members 24 may be configured to engagethe proximal surface of the target tissue when in the transverseconfiguration as described herein. The longitudinal configuration of theinternal member 26 and/or external members 24 may provide the retractiondevice 22 with a smaller profile, which may facilitate advancement andremoval of the retraction device 22 through a working space, such asthat provided by a mediastinoscope or suprasternal access device asdescribed herein.

In some embodiments, the internal member 26 and/or external members 24may be rotatably movable from the longitudinal configuration to thetransverse configuration, and vice versa. The internal member 26 may,for example, comprise a pivoting joint 50 at its attachment point to thefirst shaft 25. Alternatively or in combination, one or both of theexternal members 24 may each comprise a pivoting joint 52 at theirattachment points to the second shaft 23. The internal member 26 and/orexternal members 24 may be rotated around the pivoting joints 50, 52,respectively, in order to move the members 26, 24 between theirlongitudinal and transverse configurations. In some embodiments, theinternal member 26 and/or external members 24 may be configured to berotated from the longitudinal configuration to the transverseconfiguration in response to a force applied to the internal member 26and/or external members 24, respectively, when in the longitudinalconfiguration. In some embodiments, the internal member 26 and/orexternal members 24 may be configured to be rotated from thelongitudinal configuration to the transverse configuration in responseto removal of a force applied to the internal member 26 and/or externalmembers 24, respectively, in the longitudinal configuration. In someembodiments, the internal member 26 and/or external members 24 may bebiased towards the longitudinal configuration or the transverseconfiguration in the absence of an applied force.

The longitudinal configuration of the internal member 26 may besubstantially parallel to the longitudinal axis of the first shaft 25.The longitudinal configuration of the internal member 26 may, forexample, be within about 30°, 25°, 20°, 15°, 10°, or about 5° of thelongitudinal axis of the first shaft 25. The transverse configuration ofthe internal member 26 may be substantially perpendicular to thelongitudinal axis of the first shaft 25. The transverse configuration ofthe internal member 26 may, for example, be within about 30°, 25°, 20°,15°, 10°, or about 5° of a transverse axis of the first shaft 25.

The longitudinal configuration of the external members 24 may besubstantially parallel to the longitudinal axis of the second shaft 23.The longitudinal configuration of the external members 24 may, forexample, be within about 30°, 25°, 20°, 15°, 10°, or about 5° of thelongitudinal axis of the second shaft 23. The transverse configurationof the external members 24 may be substantially perpendicular to thelongitudinal axis of the second shaft 23. The transverse configurationof the external members 24 may, for example, be within about 30°, 25°,20°, 15°, 10°, or about 5° of a transverse axis of the second shaft 23.

In some embodiments, the internal member 26 and/or one or both of thepair of external members 24 may be coupled to one or more lockingmechanisms (for example one or more of the locking mechanisms shown inFIGS. 8A-10B) to maintain the members 26, 24 in the longitudinalconfiguration and/or transverse configuration. In some embodiments, eachof the pair of external members 24 may be coupled to at least onelocking mechanism. In some embodiments, disengaging the lockingmechanism may actuate the internal member 26 and/or one or both of thepair of external members 24 from the longitudinal configuration to thetransverse configuration. In some embodiments, disengaging the lockingmechanism may actuate the internal member 26 and/or one or both of thepair of external members 24 from the transverse configuration to thelongitudinal configuration. In some embodiments, one or more of theinternal member 26 and/or one or both of the pair of external members 24may comprise a plurality of locking mechanisms, for example a firstlocking mechanism configured to maintain the member(s) in thelongitudinal configuration and a locking mechanism configuration tomaintain the member(s) in the transverse configuration.

FIGS. 8A-8B show a mechanism for moving an internal member 26 and/orexternal members (not shown) of an endoscopic retraction device betweena longitudinal configuration and a transverse configuration. Theendoscopic retraction device may be substantially similar to theretraction device shown in FIGS. 7A-7B, with the exception that theinternal member 26 and/or one or both of the pair of external membersmay be operably coupled to one or more locking mechanisms comprising oneor more detents 58 in the pivoting joint 50 coupled to the internalmember 26 (and/or joint 52 shown in FIGS. 7A-7B when coupled to theexternal members). The detents 58 may constrain the internal member 26and/or one or both of the pair of external members in either thelongitudinal configuration or the transverse configuration relative thefirst shaft 25 or second shaft, respectively. After being advancedthrough the working space in the longitudinal position as describedherein, the internal member 26 and/or one or both of the pair ofexternal members may be pivoted to and/or from the transverseconfiguration by applying a force to the internal member 26 and/or oneor both of the pair of external members, respectively. For example, alateral load may be placed against the distal ends of the internalmember 26 and/or one or both of the pair of external members withanother instrument (such as a retractor) within the working space or byan appropriately rigid and robust anatomical structure (such as avertebral body).

In some embodiments, the internal member 26 and/or external members maybe configured to be rotated from the longitudinal configuration to thetransverse configuration in response to a force applied to the internalmember 26 and/or external members, respectively, in the longitudinalconfiguration. In some embodiments, the internal member 26 and/orexternal members may be configured to be rotated from the transverseconfiguration to the longitudinal configuration in response to a forceapplied to the internal member 26 and/or external members, respectively,in the transverse configuration. The amount of detent 58 holding forceneed to maintain the internal member 26 and/or external members in thelongitudinal position may be significantly less than the holding forceneeded to maintain the transverse position as the longitudinal positionmay only be used for advancement of the retraction device through theworking space and little or no additional load may be placed on thepivot 50 during insertion and advancement. The detent 58 holding forceneeded to maintain the transverse portion may be of sufficient force tomaintain the transverse position while manipulating the target tissue asis described herein. For example, when in the longitudinalconfiguration, the detent 58 may be configured to disengage from theinternal member 26 and/or external members when a force within a rangeof about 0.10 to about 1 pounds is applied to the internal the internalmember 26 and/or external members, respectively. Alternatively or incombination, when in the transverse configuration, the detent 58 may beconfigured to disengage from the internal member 26 and/or externalmembers when a force within a range of about 2 to about 5 pounds isapplied to the internal the internal member 26 and/or external members,respectively.

FIGS. 9A-9B show another mechanism for moving an internal member 26and/or external members (not shown) of an endoscopic retraction devicebetween a longitudinal configuration and a transverse configuration. Theendoscopic retraction device may be substantially similar to theretraction device shown in FIGS. 7A-7B, with the exception that theinternal member 26 and/or one or both of the pair of external membersmay be operably coupled to one or more locking mechanisms comprising oneor more detents 58 and one or more wire actuators 56 to maintain themembers 26, 24 in the longitudinal configuration and/or transverseconfiguration. Detents 58 may be substantially similar to thosedescribed in FIGS. 8A-8B. The wire actuator 56 may be slidably disposedwithin the first shaft 25 (or second shaft when coupled to an externalmember) and functionally coupled to the detent 58. Wire actuator 56 maybe shaped to correspond to detent 58. The detent 58 and wire actuator 56may constrain the internal member 26 and/or one or both of the pair ofexternal members in either the longitudinal configuration or thetransverse configuration relative the first shaft 25 or second shaft,respectively. After being advanced through the working space in thelongitudinal position as described herein, the internal member 26 and/orone or both of the pair of external members may be pivoted to and/orfrom the transverse configuration by sliding the wire actuators 56within the first shaft 25 or second shaft, respectively. For example,pulling on a wire actuator 56 in the direction of the hollow arrow shownin FIG. 9A may disengage the detent 58 and enable movement of theinternal member 26 and/or one or both of the pair of external membersfrom the longitudinal configuration to the transverse configuration asdescribed herein. After disengaging the locking mechanism, a much lowerlevel of lateral load may be required to move the internal member 26and/or one or both of the pair of external members from the longitudinalconfiguration to the transverse configuration compared to the lateralload that would have been need if the wire actuator 56 mechanism wereengaged with the detent 58. In some embodiments, the internal member 26and/or one or both of the pair of external members may be biased towardsa desired configuration as described herein. For example, a springelement may be included that may bias the internal member 26 and/or oneor both of the pair of external members to the transverse configurationonce the locking mechanism is disengaged. Pulling or pushing on the wireactuator 56 in the direction of the solid arrow shown in FIG. 9B mayreengage the detent 58 and lock the internal member 26 and/or one orboth of the pair of external members in a desired configuration, forexample in the transverse configuration during tissue retraction.

FIGS. 10A-10B show yet another mechanism for moving an internal member26 and/or external members 24 of an endoscopic retraction device 22between a longitudinal configuration and a transverse configuration. Theendoscopic retraction device 22 may be substantially similar to theretraction device shown in FIGS. 7A-7B, with the exception that theinternal member 26 and/or one or both of the pair of external membersmay be operably coupled to one or more locking mechanisms comprising oneor more detents 58 and one or more rigid elements 60, 62 to maintain themembers 24, 26, respectively, in the longitudinal configuration and/ortransverse configuration. Detents 58 may be substantially similar tothose described in FIGS. 8A-8B. The rigid elements 62, 60 may beoperably coupled to the internal member 26 and/or one or both of thepair of external members 24, respectively. The rigid elements 62, 60 maybe coupled to the internal member 26 and/or one or both of the pair ofexternal members 24 a short distance from the pivots 50, 52,respectively. The rigid elements 60, 62 may be slidably disposed withinthe second shaft 23 or the first shaft 25, respectively. The rigidelements 62, 60, when compressed, may be configured to apply force tothe internal member 26 and/or one or both of the pair of externalmembers 24 to maintain the internal member 26 and/or one or both of thepair of external members 24, respectively, in the longitudinalconfiguration. Tensioning the rigid elements 62, 60 may move the rigidelements 62, 60 at least a first distance away from pivots 50, 52 andremove the force applied to the internal member 26 and/or one or both ofthe pair of external members 24 to move the internal member 26 and/orone or both of the pair of external members 24 from the longitudinalconfiguration to the transverse configuration. The first distance may bea small distance, for example a distance within a range of about 1 mm toabout 20 mm. It will be understood by one of ordinary skill in the artthat the larger the distance the rigid elements 62, 60 are tensioned,the lower the force that is needed to cause rotation.

It will be understood by one of ordinary skill in the art that any ofthe locking mechanisms described herein may be combined in any desiredcombination to provide rotation of the internal member 26 and/orexternal members 24 from the longitudinal position to the transverseposition and vice versa. For example, in some embodiments the internalmember 26 and/or external members 24 may comprise one or more detents 58and one or more rigid elements 60, 62. In some embodiments, the internalmember 26 and/or external members 24 may comprise one or more detents58, one or more wire actuators 56, and one or more rigid elements 60,62. In some embodiments, each of the internal member 26 and/or externalmembers 24 may comprise the same locking mechanism. In some embodiments,one or more of the internal member 26 and/or external members 24 maycomprise a different locking mechanism.

FIG. 11A shows an endoscopic pursestring suture retractor 22 having adistal portion comprising an internal member 26 in a distalconfiguration below (distal to) a pair of spaced-apart external members24. The retraction device 22 may be substantially similar to any of theretraction devices described herein. FIG. 11B shows the endoscopicpursestring suture retractor 22 with the internal member 26 in aproximal configuration above (proximal to) two external members 24. Theinternal member 26 may be movable longitudinally relative to the pair ofexternal members 24 between a distal position and a proximal position.The internal member 26 may be longitudinally movable along a plane ofmotion extending between the pair of external members 24. This plane ofmotion may be generally perpendicular to a transverse plane containingeach of the external members 24. Translation of the crossbar 30 withinthe slots 23S may translate the first shaft 25 relative to the secondshaft 23, which may move the internal member 26 longitudinally relativeto the external members 24 between the distal position (which maycorrespond to a distal end of slot 23S) and the proximal position (whichmay correspond to a proximal end of slot 23S). When retracted from thedistal position shown in FIG. 11A, past the pair of external members 24,to the proximal position shown in FIG. 11B, the internal member 26 mayapply traction to the target tissue as described herein. The pair ofexternal members 24 may apply counter-traction to the target tissue onopposing lateral sides of the internal member 26 and re-shape the tissueas described herein.

The internal member 26 may be configured to be positioned about 0.5-3cm, and preferably 1-2 cm, distal to the pair of external members 24when in the distal position.

The internal member 26 may be configured to be positioned about 0.5-3cm, and preferably 1-2 cm, proximal to the pair of external members 24when in the proximal position.

FIGS. 12A-12C show the mechanism of retraction of a target tissue, forexample an atrial wall, using an endoscopic pursestring suture retractor22. FIG. 12A shows the retraction device 22 having a distal portioncomprising an internal member 26 in a distal configuration below a pairof spaced-apart external members 24. The retraction device 22 may besubstantially similar to any of the retraction devices described herein.The internal member 26 is shown advanced through a puncture 34 in thewall of left atrium 15 and engaged a distal, internal surface of theatrial wall. FIG. 12B shows the retractor 22 with the internal member 26in a proximal configuration above two external members 24. The internalmember 26 may be longitudinally movable relative to the pair of externalmembers 24 along a plane extending between the pair of external members24 as described herein. In some embodiments, translation of a crossbar30 may move the internal member 26 longitudinally relative to theexternal members 24 between the distal position and the proximalposition as described herein. The two external members 24 may beconfigured to engage a proximal, outer surface of the atrial wall whenthe internal member 26 is in the proximal position. Traction may beapplied to the left atrial wall by the internal member 26 as it isretracted from the distal position shown in FIG. 12A, past the pair ofexternal members 24, to the proximal positon shown in FIG. 12B. The pairof external members 24 may apply counter-traction to the target tissueon opposing lateral sides of the internal member 26 as described herein.The traction and counter-traction applied to the target tissue mayre-shape the target tissue so as to be folded over the internal member26 into a pair of generally vertical portions V, each having alaterally-facing surface 35 extending between the internal member 26 andone of the external members 24, as shown in FIG. 12C. Thelaterally-facing surfaces 35 of the tented atrial wall may allow forsuture placement, for example pursestring suture placement, forinstrument access to and incision closure in a hollow organ in confinedand narrow anatomic situations as described herein.

In some embodiments, the internal member 26 may be configured to beadvanced through the wall of the heart while the heart is beating.Alternatively or in combination, the internal member 26 may beconfigured to be advanced through the wall of the heart while a chest ofthe patient remains closed. In some embodiments, the internal member 26may be configured to apply traction to the target tissue while the heartis beating. Alternatively or in combination, the internal member 26 maybe configured to apply traction to the target tissue while a chest ofthe patient remains closed.

FIG. 13 shows the configuration of the curved needle 19 and the surgicalneedle holder 21 when used with an endoscopic pursestring sutureretractor 22 to place one or more sutures in the target tissue. The oneor more sutures may, for example, be placed in the tissue in apursestring pattern as described herein. The tissue retractor 22 isshown in the proximal configuration with the internal member 26 and theexternal members 24 re-shaping the tissue 15 form a pair oflaterally-facing walls 35 therein. Unlike the situation shown in FIG. 5using conventional techniques, the pair of laterally-facing walls 35 mayenable the surgical needle holder 21 to hold the curved needle 19 in acorrect orthogonal orientation in order to place one or more sutures inthe laterally-facing walls 35 of the target tissue while remaininginside the working space 17 allotted by a minimally-invasive approach,such as through a mediastinoscope or suprasternal access device asdescribed herein. The pair of laterally-facing walls may furtherfacilitate axial rotation of the needle holder 21 within the workingspace. Using the systems, devices, and methods described herein, thetissue may thus be re-shaped to facilitate the range of motion of needleholder 21 needed for suture placement within the available working space17 of a minimally-invasive access pathway.

FIGS. 14A-14E show placement of an endoscopic pursestring sutureretractor 22 into the left atrium 15 of the heart.

FIGS. 14A-14C show placement of a guidewire 37 into the left atrium 15of the heart via a needle 36. A long needle 36 may be advanced from aremote opening in the skin of the patient, for example at thesuprasternal notch as described herein, and through a working space toreach a target tissue, shown here as the roof of the left atrium 15. Insome embodiments, the needle 36 may be inserted into the body of thepatient via a working channel of a surgical instrument, an endoscope, amediastinoscope, or a suprasternal access device placed through theremote opening in the body of the patient. The needle 36 may be insertedinto the dome of the left atrium 15 to enable access to the interior ofthe heart for a guidewire 37 advanced therethrough. Correct positioningof the needle 36 in the heart of the patient may be confirmed by thepresence of bright red, oxygenated blood exiting a proximal hub of theneedle 36. Incorrect positioning of the needle 36 in the pulmonaryartery may be confirmed by the presence dark, un-oxygenated blood.Fluoroscopy or transesophageal echocardiogram can also or alternativelybe used to confirm correct positioning of the needle 36. Once theposition of the needle 36 has been confirmed, the guidewire 37 may beadvanced into the left atrium 15 through the needle 36 as shown in FIG.14B. The needle 36 may then be removed from the left atrium 15 (and thepatient). The guidewire 37 may be left in the atrium 37 after removal ofneedle 36 from the patient as shown in FIG. 14C.

FIG. 14D shows an endoscopic pursestring suture retractor 22 loaded ontothe guidewire 17 following needle 26 removal. The tissue retractor 22may be inserted into the body of the patient through an incision in theskin of the patient, for example at the suprasternal notch, as describedherein. In some embodiments, the tissue retraction device 22 may beinserted into the body of the patient via a working channel of asurgical instrument, an endoscope, a mediastinoscope, or a suprasternalaccess device placed through the remote opening in the body of thepatient. The tissue retractor 22 may be advanced along the guidewire 37towards the puncture site 34 in the left atrium 15 as described herein.

FIG. 14E shows advancement of the endoscopic pursestring sutureretractor 22 along the guidewire 37 into the left atrium 15 of the heartthrough a puncture site 34. The internal member 26 may be configured tobe advanced through the target tissue of the left atrium 15 over theguidewire 37 slidably disposed therein as described herein. In someembodiments, the internal member 26 may be configured to create and/orexpand a penetration at the puncture site 34 through which the internalmember 26 may be advanced into the interior of the heart. For example,the internal member 26 may deliver electrocautery energy to the targettissue to create the penetration at puncture site 34. Alternatively orin combination, a distal end of the internal member 26 may be shaped tofacilitate penetration of the tissue as described herein. The leftatrium 15 may be sealed with the internal member 26 while it engages thedistal surface of the left atrial wall to inhibit leakage of blood fromthe puncture site 34 as described herein.

After the internal member 26 has been advanced through the left atrialwall tissue, the tissue may be re-shaped as described herein tofacilitate placement of one or more sutures. The suture(s) may, forexample, be placed by a curved needle in a pursetring suture pattern asdescribed herein. Alternatively or in combination, the suture(s) may beplaced by a curved needle as a plurality of interrupted stitches asdescribed herein.

After the sutures have been placed in the tissue, an incision may bemade in the tissue within the one or more sutures placed therein. Theincision may be made by applying electrocautery energy to the tissuewith the internal member 26 as described herein. Alternatively or incombination, the incision may be made by cutting the tissue with ablade, for example a scalpel, an elongated curved blade extending from amediastinoscope or other surgical instrument, or the like. Directscalpel incision may be advantageous in at least some instances wherethe use of electrocautery may create unwanted tissue char. Alternativelyor in combination, the incision may be made by advancing acardiovascular sheath and dilator through the target tissue and dilatingthe dilator therein. After removal of the guidewire 37, internal member26, and/or any other surgical instrument described herein from thetissue, the incision may be closed by tightening or knotting the one ormore sutures around the incision as described herein.

After the sutures have been placed in the tissue, the internal member 26may be removed from the target tissue and the interior of the holloworgan (e.g. heart). For example, the internal member 26 may be slidablyremoved over the guidewire 37 such that the guidewire 37 remainsdisposed through the tissue after the internal member 26 is removed.Alternatively, the guidewire 37 may be removed prior to orsimultaneously with removal of the internal member 26. In someembodiments, the guidewire 37 may be removed before placement of thesutures, reintroduced after placement of the sutures, and then left inthe tissue after removal of the internal member 26 to provide a pathwayfor additional instruments or catheters to access the heart, for examplea surgical instrument to perform a surgical procedure within the heartas described herein.

In some embodiments, the heart may remain beating during one or more ofthe steps of inserting the endoscopic retraction device 22 into thepatient, advancing the distal portion of the device 22 toward the leftatrium 15, advancing the internal member 26 through the roof of the leftatrium 15, applying traction to the left atrial wall, placing the one ormore sutures, and/or incising the left atrial wall as described herein.It will be understood by one of ordinary skill in the art that anycombination of method steps described herein may be performed while theheart is beating.

In some embodiments, the chest of the patient may remain closed duringone or more of the steps of inserting the endoscopic retraction device22 into the patient, advancing the distal portion of the device 22toward the left atrium 15, advancing the internal member 26 through theroof of the left atrium 15, applying traction to the left atrial wall,placing the one or more sutures, and/or incising the left atrial wall asdescribed herein. It will be understood by one of ordinary skill in theart that any combination of method steps described herein may beperformed while the chest of the patient is closed.

FIG. 15 shows a surgical instrument 38 inserted through an incision inthe center of a pursestring suture 20 placed with the help of anendoscopic retractor as described herein. After the pursestring suture20 has been placed and the endoscopic retraction device has been removedfrom the tissue, at least a distal portion of the surgical instrument 38may be inserted through the incision to access the internal structuresof the hollow organ, for example the heart. The incision may be sealedaround the surgical instrument 38 in order inhibit leakage of blood fromthe heart. For example, the sutures may be tightened around the surgicalinstrument 38 to seal the incision therearound. The suture ends 18 ofthe pursestring suture 20 may be threaded through a flexible polymertube 39 or the like and held with a surgical clamp therein in order tokeep the sutures tight around the surgical instrument 38 to maintainhemostasis. The ends of suture(s) 18 may be externalized or brought outof the body via the skin incision. Use of a clamped polymer tube 39 tomaintain tension on a cinched pursestring suture 20 is referred to as aRumel tourniquet.

The surgical instrument 38 may be configured to perform a surgicalprocedure inside the heart after being inserted through the incision 40.The surgical procedure may, for example, comprise at least one of mitralvalve replacement, mitral valve repair, mitral annuloplasty, chordalrepair, chordal replacement, leaflet resection, or leaflet coaptation.The surgical procedure may, for example, comprise at least one of atrialappendage closure, atrial ablation, pulmonary vein ablation, septaldefect closure, aortic valve repair, aortic valve replacement, tricuspidvalve repair, tricuspid valve replacement, implantable cardiacdefibrillator (ICD) implantation, pacemaker implantation, or placementof leads for ICD's or pacemakers, myocardial biopsy, or septectomy. Itwill be understood by one of ordinary skill in the art that the surgicalprocedure will depend on the hollow organ of interest.

FIG. 16 shows cinching of the pursestring suture to close the leftatrial incision 40 following removal of a surgical instrument 38 fromthe heart. The polymer tube tensioning the suture ends 18 may be removedprior to, at the same time as, or after the surgical instrument 38 isremoved from the incision 40. The incision 40 may then be closed bytightening or knotting the one or more sutures around the incision 40.For example, a pursestring suture 20 may be cinched around the incision40 by drawing the ends 18 of the pursestring suture 20 tight. Theincision 40 may then be permanently closed by forming a plurality ofsquare knots 41 in the suture 18. Alternatively or in combination, thesuture may comprise a plurality of interrupted stitches as describedherein which may be knotted to close the incision 40 as described hereinafter the surgical instrument 38 has been removed.

FIG. 17 shows placement of interrupted sutures in the left atrium 15using an endoscopic pursestring suture retractor 22. The tissueretractor 22 is shown in the proximal configuration with the internalmember 26 and the external members 24 re-shaping the tissue 15 form apair of laterally-facing walls 35 therein as described herein. Thesurgical needle holder 21 may be used to place a plurality ofinterrupted sutures 18 in the left atrium 15, with all devices remainingwithin the working space 17 of a mediastinoscopic or suprasternalapproach pathway. Multiple suture strands 18 coupled to multiple curvedneedles may be inserted within the pair of laterally facing walls 35,distal to the position of the internal member 26, while the internalmember 26 re-shapes the tissue as described herein. Following placementof the interrupted sutures 18, an incision may be created within thesutures 18 as described herein.

FIG. 18A shows placement of interrupted sutures 18 around an incision 40in the left atrium 15. A plurality of suture strands 18 may be spacedalong the tissue wall around the atrial incision 40. The incision 40 maybe closed by tying or knotting the plurality of interrupted sutures 18,or example with a plurality of square knots 41.

In some embodiments, one or more of the steps for placement of thetissue retractor 22 into the target tissue shown in FIGS. 14A-14E anddescribed herein, and/or one or more the steps for tissue retractionshown in FIGS. 12A-12B, and/or one or more of the steps for sutureplacement shown in FIGS. 13 and 17, and/or one or more of the steps forincising the target tissue shown in FIGS. 14A-15, and/or one or more ofthe steps for placement or removal of a surgical instrument shown inFIGS. 15 and 16, and/or one or more of the steps for closing theincision in the target tissue shown in FIGS. 16 and 18, and/or one ormore of any of the method steps described herein may be performed whilevisualizing the target tissue and/or the structures along the accesspath to the target tissue with a visualization device. The visualizationdevice may, for example, comprise a mediastinoscope, a camera coupled tothe distal portion of the endoscopic tissue retraction device, anoptical channel in the endoscopic tissue retraction device, and/or anendoscope or the like which will be known to one of ordinary skill inthe art. For example, the visualization device may comprise amediastinoscope containing an endoscope for visualization of internalstructures on a video monitor.

It will be understood by one of ordinary skill in the art that theendoscopic tissue retractor devices, systems, and methods describedherein may be used to place any suture pattern desired by one ofordinary skill in the art for access inside a hollow organ. For example,the endoscopic tissue retractor devices, systems, and methods describedherein may be used to place a pursestring suture and/or a plurality ofinterrupted sutures as described herein.

It will also be understood that, although the terms first, second, etc.are, in some instances, used herein to describe various elements, theseelements should not be limited by these terms. These terms are only usedto distinguish one element from another. For example, a first shaftcould be termed a second shaft, and, similarly, a second shaft could betermed a first shaft, without departing from the scope of the variousdescribed implementations. The first shaft and the second shaft are bothshafts, but they are not the same shaft unless explicitly stated assuch.

The terminology used in the description of the various describedimplementations herein is for the purpose of describing particularimplementations only and is not intended to be limiting. As used in thedescription of the various described implementations and the appendedclaims, the singular forms “a”, “an” and “the” are intended to includethe plural forms as well, unless the context clearly indicatesotherwise. It will also be understood that the term “and/or” as usedherein refers to and encompasses any and all possible combinations ofone or more of the associated listed items. It will be furtherunderstood that the terms “includes,” “including,” “comprises,” and/or“comprising,” when used in this specification, specify the presence ofstated features, integers, steps, operations, elements, and/orcomponents, but do not preclude the presence or addition of one or moreother features, integers, steps, operations, elements, components,and/or groups thereof

The foregoing description, for purpose of explanation, has beendescribed with reference to specific implementations. However, theillustrative discussions above are not intended to be exhaustive or tolimit the scope of the claims to the precise forms disclosed. Manymodifications and variations are possible in view of the aboveteachings. The implementations were chosen in order to best explain theprinciples underlying the claims and their practical applications, tothereby enable others skilled in the art to best use the implementationswith various modifications as are suited to the particular usescontemplated.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following claims define the scope of the invention and that methodsand structures within the scope of these claims and their equivalents becovered thereby.

What is claimed is:
 1. An endoscopic tissue retraction device,comprising: a first shaft; a second shaft slidably coupled to the firstshaft and longitudinally movable relative thereto; an internal membercoupled to the first shaft so as to extend therefrom in a transversedirection, the internal member being configured for advancement througha penetration in a target tissue of a patient and having aproximally-facing surface configured to atraumatically engage a distalsurface of the target tissue after being advanced therethrough; and apair of external members each coupled to the second shaft so as toextend therefrom generally parallel to the transverse direction, theexternal members being spaced apart and each having a distally-facingsurface configured to atraumatically engage a proximal surface of thetarget tissue, wherein the internal member is movable longitudinallyrelative to the external members between a distal position and aproximal position along a plane extending between the external members,the internal member being configured to apply traction to the targettissue when retracted from the distal position towards and past the pairof external members to the proximal position, and wherein the pair ofexternal members are configured to apply counter-traction to the targettissue on opposing lateral sides of the internal member, whereby thetarget tissue is re-shaped so as to have a pair of laterally facingsurfaces each extending between the internal member and one of theexternal members.
 2. The device of claim 1, wherein the first shaft isrigid.
 3. The device of claim 1, wherein the second shaft is rigid. 4.The device of claim 1, wherein the second shaft is configured to beinserted into a working channel of a surgical instrument, an endoscope,a mediastinoscope, or a suprasternal access device placed through anopening in the body of the body of the patient.
 5. The device of claim1, wherein the first shaft is slidably disposed within at least aportion of the second shaft.
 6. The device of claim 1, wherein thetarget tissue is a wall of a heart of the patient.
 7. The device ofclaim 6, wherein the internal member is configured to apply traction tothe target tissue while the heart is beating.
 8. The device of claim 1,wherein the internal member is configured to be movable from alongitudinal configuration to a transverse configuration, and whereinthe internal member is configured to engage the distal surface of thetarget tissue when in the transverse configuration, and furthercomprising a rigid element coupled to the internal member and configuredto apply force to the internal member to maintain the internal member inthe longitudinal configuration when compressed, wherein tensioning ofthe rigid element moves the rigid elements at least a first distance andremoves the force applied to the internal member to actuate the internalmember from the longitudinal configuration to the transverseconfiguration, wherein the first distance is within a range of about 1mm to about 20 mm.
 9. The device of claim 1, wherein the internal memberis configured to be movable from a longitudinal configuration to atransverse configuration, and wherein the internal member is configuredto engage the distal surface of the target tissue when in the transverseconfiguration, and further comprising a locking mechanism coupled to theinternal member and configured to maintain the internal member in thelongitudinal configuration, wherein disengaging the internal member fromthe locking mechanism actuates the internal member from the longitudinalconfiguration to the transverse configuration.
 10. The device of claim1, wherein a distal tip of the internal member is tapered to sharpenedto facilitate advancement through the target tissue.
 11. The device ofclaim 1, wherein the internal member comprises a guidewire lumenconfigured to slidably receive a guidewire therethrough.
 12. The deviceof claim 11, wherein the internal member comprises an elastomeric sealdisposed within the guidewire lumen and configured to seal the targettissue and prevent fluid flow through the guidewire lumen.
 13. Thedevice of claim 1, wherein the pair of external members are moveablefrom a longitudinal configuration to a transverse configuration, andwherein the pair of external members are configured to engage theproximal surface of the target tissue when in the transverseconfiguration.
 14. The device of claim 13, wherein the pair of externalmembers are configured to be rotated from the longitudinal configurationto the transverse configuration.
 15. The device of claim 14, furthercomprising at least two rigid elements coupled to the pair of externalmembers, respectively, and configured to apply force to the pair ofexternal members to maintain the pair of external members in thelongitudinal configuration when compressed, wherein tension of the atleast two rigid elements moves the at least two rigid elements at leasta first distance and removes the force applied to the pair of externalmembers to actuate the pair of external members from the longitudinalconfiguration to the transverse configuration, wherein the firstdistance is within a range of about 1 mm to about 20 mm.
 16. The deviceof claim 1, wherein the first shaft comprises a suction lumen configuredto remove blood or bodily fluids from the target tissue.
 17. A surgicalsystem, comprising: the device of claim 1; one or more sutures; and acurved needle coupled to the one or more sutures and configured to placethe one or more sutures in the target tissue when the internal memberapplies traction to the target tissue.
 18. A surgical system,comprising: the device of claim 1; and a visualization device comprisinga mediastinoscope, a camera coupled to a distal portion of theendoscopic tissue retraction device, an optical channel in theendoscopic tissue retraction device, or an endoscope.